Details for New Drug Application (NDA): 208079

NDA 208079 describes SERNIVO, which is a drug marketed by Primus Pharms and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SERNIVO profile page.

The generic ingredient in SERNIVO is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

Summary for 208079

Tradename:	SERNIVO
Applicant:	Primus Pharms
Ingredient:	betamethasone dipropionate
Patents:	7

Pharmacology for NDA: 208079

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Suppliers and Packaging for NDA: 208079

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079	NDA	Primus Pharmaceuticals, Inc.	68040-714	68040-714-08	1 BOTTLE, SPRAY in 1 CARTON (68040-714-08) / 10 g in 1 BOTTLE, SPRAY
SERNIVO	betamethasone dipropionate	SPRAY;TOPICAL	208079	NDA	Primus Pharmaceuticals, Inc.	68040-714	68040-714-28	1 BOTTLE, SPRAY in 1 CARTON (68040-714-28) / 120 g in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SPRAY;TOPICAL			Strength	EQ 0.05% BASE/SPRAY
Approval Date:	Feb 5, 2016	TE:		RLD:	Yes
Patent:	10,179,137	Patent Expiration:	Aug 31, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PLAQUE PSORIASIS
Patent:	9,364,485	Patent Expiration:	Aug 31, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PLAQUE PSORIASIS
Patent:	9,433,630	Patent Expiration:	Aug 31, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PLAQUE PSORIASIS

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